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临床试验/CTRI/2018/01/011617
CTRI/2018/01/011617已完成Unknown

A Randomized, Double Blind, Placebo Controlled, Four Arm, Parallel Group Study To Evaluate The Comparative Efficacy Of Different Forms And Doses Of Curcumin With That Of A Placebo In Active Rheumatoid Arthritis Patients.

Plant Lipids P Limited1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2016年2月15日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
48
试验地点
1
主要终点
To evaluate the comparative efficacy of curcumin (low & high dose), white curcumin with that of a placebo

研究概览

简要总结

A randomized, double blind, placebo controlled,four arm, parallel group study To evaluate the comparative efficacy of curcumin(low & high dose), white curcumin with that of a placebo

研究设计

研究类型
Observational

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • i.Patients with active RA for at least one (1) year, diagnosed according to the revised 1987 American College of Rheumatology (ACR) criteria for the classification of rheumatoid arthritis.
  • ii.Receiving treatment on an outpatient basis.
  • iii.Active disease at the time of screening.

排除标准

  • 未提供

结局指标

主要结局

To evaluate the comparative efficacy of curcumin (low & high dose), white curcumin with that of a placebo

时间窗: Screening – (Day - 7) | Baseline visit – (Day 0) | Visit 2 (Day 30) | Visit 3 (Day 60) | Visit 4 (Day 90)

次要结局

  • a.To assess the safety & tolerability of active products(b.To assess changes in various biomarkers during the study period among all the study group subjects.)

研究者

发起方
Plant Lipids P Limited
申办方类型
Pharmaceutical industry-Indian

研究点 (1)

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